21 C.F.R. § 862.1390

Current through October 31, 2024
Section 862.1390 - 5-Hydroxyindole acetic acid/serotonin test system
(a)Identification. A 5-hydroxyindole acetic acid/serotonin test system is a device intended to measure 5-hydroxyindole acetic acid/serotonin in urine. Measurements of 5-hydroxyindole acetic acid/serotonin are used in the diagnosis and treatment of carcinoid tumors of endocrine tissue.
(b)Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9 .

21 C.F.R. §862.1390

52 FR 16122, May 1, 1987, as amended at 65 FR 2306 , Jan. 14, 2000